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Amgen and Johnson & Johnson are recalling certain lots of the anemia drugs Epogen and Procrit because vials of the injectable medicines might develop tiny glass flakes that could cause blood clots and other serious health problems.
Amgen and Johnson & Johnson are recalling certain lots of the anemia drugs Epogen (epoetin alfa, Amgen) and Procrit (epoetin alfa, Johnson & Johnson) because vials of the injectable medicines might develop tiny glass flakes that could cause blood clots and other serious health problems.
Amgen manufactures the drugs at a plant in Puerto Rico.
Emma Hurley, an Amgen spokeswoman, said that the recall, which included 200 lots of Epogen, is not expected to disrupt availability of the drug and the biotechnology company does not expect a material financial impact.
Lisa Vaga, a Johnson & Johnson spokeswoman, said that 155 lots of Procrit were recalled. She declined to comment on any financial impact to the company.
According to Amgen, there have been no patient complaints that can be directly attributed to the presence of glass. The lots are being voluntarily recalled as a precaution.
The glass flakes result from the interaction of the drug with glass vials over the shelf life of the product, a company statement said.
Hurley said that expiration dates for the drugs have been reduced to 12 months for single-dose vials and 15 months for multi-dose vials. Their shelf life had been 36 months. She added that the company would switch vial manufacturers.
Amgen sells Epogen in the United States, where it is used mostly by kidney dialysis patients. Under a longstanding license agreement with Amgen, Johnson & Johnson’s Centocor Ortho Biotech unit distributes Procrit in the United States, mainly for cancer and HIV patients.
To see the list of Procrit lots recalled by Johnson & Johnson, go to
To see the list of Epogen lots recalled by Amgen, go to www.epogen.com/professional/pdf/epogen-consignee-notification-letter.pdf.